Authorisations and variations

In connection with the revision of the Therapeutic Products Act, new procedures will be introduced, including "temporary authorisation" for promising, urgently needed innovative medicinal products with hitherto incomplete clinical data, or for well-established medicinal products that were introduced in another country a long time previously (Art. 14 para. 1 abis-quater TPA). 

The key innovation in relation to authorisations and variations is the introduction of the structure for variations to match that in the EU. 

A simplified notification procedure for complementary and herbal medicines will also be established.

Last modification 03.05.2018

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